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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01458-1
Product Name/Description SynchroMed II Implantable Drug Infusion Pump

ARTG Number: 97770
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 24/11/2016
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue This communication is an update to Medtronic’s March 2014 notification regarding the potential for SynchroMed II pump over-infusion. “Over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. Pump reservoir contents that are less than expected may indicate that the pump has over-infused. Over-infusion may or may not be associated with clinically relevant symptoms. When the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. Patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. The low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. The low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir.
Recall Action Hazard Alert
Recall Action Instructions Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see . This action has been closed-out on 26/05/2017.
Contact Information 1800 652 972 - Medtronic Neuromodulation Patient Services